Study on Ketorolac for Improving Outcomes and Prognosis in Patients With Stanford Type A Aortic Dissection

Phase 3RecruitingNCT06968806

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School360 enrolled

Overview

This multicenter, randomized, double-blind, placebo-controlled trial evaluates the efficacy and safety of ketorolac in 360 patients with Stanford Type A aortic dissection, conducted between 2025 and 2027. Participants will receive either ketorolac (60 mg intramuscularly \[IM\] preoperatively and 30 mg twice daily \[BID\] for two days postoperatively) or placebo in addition to standard care. Study outcomes include composite clinical endpoints, postoperative complications, and adverse events, which will be assessed through clinical evaluations, laboratory testing, and imaging studies at predefined intervals up to 90 days. The objective of this trial is to determine whether perioperative administration of ketorolac improves clinical outcomes in this patient population.

This multicenter, randomized, double-blind, controlled clinical trial will enroll 360 eligible patients with Stanford Type A aortic dissection between March 2025 and December 2027. Participants will be equally randomized to receive either ketorolac (intervention group: 60 mg intramuscular \[IM\] preoperatively followed by 30 mg twice daily \[BID\] for two days postoperatively) or matching placebo (control group), with both groups receiving standard perioperative care including analgesia, blood pressure control, and surgical treatment. Comprehensive data collection will include demographic characteristics, clinical parameters, laboratory tests (complete blood count \[CBC\], biochemistry, coagulation profile, cardiac enzymes, procalcitonin, cultures), and imaging studies (radiomics, biomechanics, chest X-ray, ultrasound, computed tomography \[CT\], magnetic resonance imaging \[MRI\]) at multiple timepoints from admission through 90-day follow-up. The primary outcomes will focus on evaluating the efficacy and safety of ketorolac through analysis of composite endpoint events, complication rates, and adverse reactions, with immediate study discontinuation and reporting for any treatment-related adverse events. All treatment protocols will maintain identical administration schedules and formulations between groups, with the exception of the active drug versus placebo.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with Stanford Type A aortic dissection confirmed by imaging and scheduled for emergency surgery. Aged between 18 and 65 years. Signed informed consent. Exclusion Criteria: * Patients who are unable to eat independently or require prolonged fasting. History of malignant tumors. Body weight \<50 kg. Traumatic aortic dissection. Patients with Marfan syndrome. Unstable vital signs requiring preoperative mechanical support or resuscitation (e.g., IABP \[Intra-Aortic Balloon Pump\], ECMO \[Extracorporeal Membrane Oxygenation\], LVAD \[Left Ventricular Assist Device\]) Patients requiring preoperative endotracheal intubation. Consciousness impairment, central nervous system dysfunction, or evidence of cerebral malperfusion syndrome upon admission. Preoperative hematemesis, melena, fresh blood in stool, or symptoms of bowel dilation. Clear evidence of limb malperfusion before surgery. Presence of organ malperfusion syndrome. Patients requiring interventional procedures to relieve organ malperfusion before surgery. History of gastrointestinal ulcers or chronic gastrointestinal inflammatory diseases. History of dialysis or renal insufficiency before admission. History of liver disease. Allergy to ketorolac tromethamine, aspirin, or other nonsteroidal anti-inflammatory drugs (NSAIDs). Chronic inflammatory diseases, autoimmune diseases, or long-term use of steroids or NSAIDs for other reasons. Absence of cerebral perfusion during deep hypothermic circulatory arrest. History of major surgery or acute myocardial infarction within 90 days. History of cardiac or major vascular surgery. Pregnant or lactating women. Patients who refuse to participate in this clinical trial or decline to sign the informed consent form. Any other conditions deemed unsuitable for participation by the investigator.

Outcomes

Primary Outcomes

Composite Endpoint: Mortality, Malperfusion Syndrome, Permanent Organ Dysfunction, Unplanned Cardiac Reoperation, and Prolonged Hospitalization

The composite endpoint includes death (the worst outcome); malperfusion syndrome (including myocardial ischemia, stroke, lower limb paralysis, acute abdominal syndrome, renal failure requiring temporary dialysis, or symptoms and signs of limb ischemia); permanent dialysis, tracheostomy, or neurological deficits at discharge; postoperative mechanical circulatory support or unplanned cardiac reoperation (excluding reoperation for bleeding); postoperative cardiac arrest, multiple organ failure, or mechanical ventilation support for more than 72 hours; and postoperative hospital stay of 91 days or longer.

Time frame: Continuous intervention for 3 days after admission, with a 1-year follow-up.

Secondary Outcomes

erythrocyte sedimentation rate (ESR)

erythrocyte sedimentation rate (ESR), an indicator of systemic inflammation that reflects the rate at which red blood cells settle in a vertical tube over a specified period. Elevated ESR levels may suggest ongoing inflammatory responses, infection, or tissue injury